The Efficacy of Aspirin Combined With Hydroxychloroquine Treatment in High Risk Pregnancies for Preeclampsia
NCT ID: NCT05287321
Last Updated: 2024-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
58 participants
INTERVENTIONAL
2022-05-31
2026-12-31
Brief Summary
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Detailed Description
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The study population consists of the singleton pregnancy at high risk for preeclampsia who had adverse pregnancy outcome (preeclampsia or fetal growth restriction or intrauterine fetal death) in previous pregnancy.
After randomisation, participants are assigned to receive hydroxychloroquine 200mg with aspirin 100mg per day or aspirin 100mg per day. Treatment is initiated between 12 and 22 weeks' gestation and stopped at 36 weeks' gestation.
The medication adherence to dosing should be maintained at more than 80%.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Aspirin 100mg + Hydroxychloroquine 200mg
Aspirin 100mg 1T daily PO + Hydroxychloroquine 200mg 1T daily PO
Hydroxychloroquine
Hydroxychloroquine 200mg with Aspirin 100mg
Interventions
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Hydroxychloroquine
Hydroxychloroquine 200mg with Aspirin 100mg
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Includes at least one factors of the below
① History of preeclampsia
② History of fetal growth restriction
③ History of intrauterine fetal death
3. Women who have agreed to enroll in the study and given their informed consent
Exclusion Criteria
2. Previous inclusion in other intervention study within 3 months of screening (except for non-interventional observational studies)
3. Major malformation of the fetus is diagnosed at 11-13 weeks of gestation
4. Elevated blood concentrations of creatinine more than double the normal value
5. Elevated blood concentrations of liver transaminases (AST(GOT) or ALT(GPT)) more than three times the normal value
6. Conditions related with aspirin treatment
* Previous exposure within 28 days of screening
* Previous NSAID exposure within 28 days of screening
* Bleeding disorder (von Willebrand's disease, peptic ulceration)
* Hypersensitivity to aspirin
7. Conditions related with hydroxychloroquine treatment
* Previous exposure within 28 days of screening
* Hypersensitivity to hydroxychloroquine and 4-aminoquinoline compounds
* Maculopathy
* Medications that has potential for visual disturbance
* Women who have potential for changes in the retina or visual impairment by 4-aminoquinoline compounds
* Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
* Prolonged QT interval on EKG (congenital or acquired) or The risk factors of QT prolongation (heart failure, arrhythmia, myocardial ischemia)
* Low level of potassium in the blood
* Low level of magnesium in the blood
8. Not suitable for participant based on medical evidence by investigator
19 Years
50 Years
FEMALE
No
Sponsors
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Ministry of Health & Welfare, Korea
OTHER_GOV
Yoo-min Kim
OTHER
Responsible Party
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Yoo-min Kim
Assistant professor
Principal Investigators
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Yoo-min Kim, MD
Role: PRINCIPAL_INVESTIGATOR
Chung-Ang University Gwangmyeong Hospital
Locations
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Chung-Ang University Hospital
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Yoo-min Kim, MD
Role: primary
References
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Kim YM, Seong J, Kim JH, Nam G, Kim GJ, Cha HH, Seong WJ, Sung JH, Choi SJ, Oh SY, Roh CR. Efficacy of combining aspirin with hydroxychloroquine in pregnancies at high risk for pre-eclampsia: a prospective, multicentre, open-label, single-arm clinical trial, investigator-initiated study (HUGS study). BMJ Open. 2024 Dec 10;14(12):e081610. doi: 10.1136/bmjopen-2023-081610.
Other Identifiers
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2112-014-487
Identifier Type: -
Identifier Source: org_study_id